Process Validation For Medical Devices – NUS - NUSAGE ...

NUSAGE- PharmEng 2012 Professional Training Program
Process Validation for Medical Devices
Objective
The objective of this course is to provide an introduction to the fundamentals of process
validation, explaining how, when, where and why you should validate. Participants will learn
more how to comply with FDA and international regulations for validation protocols. Also
included is comparison of major global medical device regulations and updates of US, EU,
Canada, A.S.E.A.N, Japan and Singapore.
Description
The FDA guideline on “General Principles of Process Validation” was first issued in May,
1987, and since then, medical device companies have struggled with the principles of
process validation as much of the industry focused on pharmaceutical processes. A
successful validated process may result in a reduced time to market for new products. Using
the tools developed in this course participants will be able to methodically plan and conduct
a process validation for medical devices.
Course Outline
• Introduction
• Purpose and scope
• Process Validation Terminology
• Introduction to Process Validation - Process validation requirements
o Requirements of 21 CFR Part 820.75
o Requirements of ISO 13485:2003 and ISO 14971:2007
o Recommendations of GHTF N99-10
o Difference between validation and verification
o Types of validation (i.e. Prospective, Concurrent and Retrospective Validation)
• Implementing a Process Validation System - Elements of process validation
o Master Validation Plan (MVP)
o Installation, Operation, and Performance Qualification (IQ, OQ, PQ)
o Application of risk management to process validation
• Executing a Validation
o Process validation steps
o Validation protocol design and final report
o Cleaning Validation
• Maintaining a state of validation
o Monitor and control
o Changes in process and/or product
o Continued state of control
• Comparing Medical Device Regulations and Updates of EU, US, Canada, ASEAN, Japan
and Singapore
About the Trainer
Kenny Peng, RAC, P.Eng., is
Director, Asia, for PharmEng
Technology. Kenny is a licesned
professional engineer (Canada), a
certified regulatory affairs
professional, and consults
professionally in the Asia-Pacific
region. Kenny graduated with a
Masters degree in Engineering from
the University of Waterloo,
Canada. His early career began
with research work during
university years in biomaterials
(University of Toronto) and in
nonlinear mechatronic systems
(University of Waterloo), where
some of the technologies have
since been successfully
commercialized. His subsequent
consulting career began with the
design and engineering of
pharmaceutical manufacturing
equipment and facilities in North
America, which led to the
commissioning/qualification/valida
tion of pharmaceutical and medical
device manufacturing facilities and
processes. Since 2008, Kenny has
successfully assisted medical
devices companies across Asia
through 5 US FDA audits, as well as
numerous ISO audits. Today, his
work involves start-up, technology
transfer, regulatory affairs,
validation, and engineering for
pharmaceutical and medical device
companies across Southeast and
Northeast Asia. Kenny is a native
speaker/writer in English and
Chinese.
Who should attend and what the participants will learn from the course
This two-day course is targeted toward professionals directly involved in meeting the
international and FDA’S Quality System Validation requirements. This includes
professionals in regulatory affairs, quality assurance, process development or
manufacturing. This course provides regulatory/quality systems professionals,
manufacturing engineering, and process development engineers with the knowledge and
skills needed to comply with the process validation requirements of the FDA’s Quality
System Regulation, ISO 13485 and GHTF Validation guidance N99-10. The course is also
intended for Medical Device professionals who are responsible for performing process
validation studies and ensuring compliance with regulatory requirements for validation
documentation.